Drug Concentration of Metformin According to Sampling Method

Clinical Trial to Evaluate Drug Concentration of Metformin According to Sampling Method in Healthy Adult Volunteers

This study assess the drug concentration of metformin in healthy adult volunteers according to the sampling method.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Venous blood collection; Other: Peripheral blood collection

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male subjects who, at the time of screening, are the age of older than 19 years
• Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
• There is no congenital disease or within 3 years of chronic diseases
• Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests
• Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
• A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
• History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
• A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product.
• A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
• A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
• A smoker who consumes more than 20 cigarettes/day within 6 months
• A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
• A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Metformin	Other: Venous blood collection; Venous blood collection; Other: Peripheral blood collection; Peripheral blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Metformin	Compare the concentration of Metformin measured from Venous blood collection and Peripheral blood collection.	10 hours

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2019
• Primary Completion (ACTUAL): June 5, 2019
• Study Completion (ACTUAL): June 5, 2019

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CUH_2019_MSM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No